Non Hodgkin Lymphoma Clinical Trial
Safety of Romiplostim (Nplate®) Following UCBT
Summary
This is a single institution, phase I dose escalation study of weekly romiplostim post umbilical cord blood transplantation in patients who fail to achieve platelet engraftment by day +30. Engraftment is defined as a platelet count ≥ 20 x 109/L on 3 consecutive measurements without transfusion for 7 days. Romiplostim is administered at the assigned dose as 6 weekly injections beginning by day +42 post transplant. Up to 4 dose levels (4, 6, 8, and 10 mcg/kg/dose) will be evaluated with the maximum tolerated dose (MTD) of romiplostim determined by using the Continual Reassessment Method (CRM). The goal of this CRM will be to identify 1 of the 4 dose levels which corresponds to the desired maximum toxicity rate of 20% or less.
Eligibility Criteria
Inclusion Criteria:
Any patient who has undergone a single or double umbilical cord blood transplant (UCBT) except those with primary myelofibrosis.
Those with acute leukemia must be in remission at the time of transplant
Must have achieved neutrophil engraftment (defined as an ANC >500 for three consecutive days) and be off daily G-CSF prior to starting romiplostim. Intermittent G-CSF is allowed.
Failure to achieve platelet engraftment (defined as platelet count ≥20x10^9/L on 3 consecutive measurements without transfusion for 7 days) by day +28 post UCBT
Between day +28 and day +42 status post myeloablative or nonmyeloablative UCBT (single or double cord blood transplant)
Age ≥ 18 years
Adequate organ function within 7 days of enrollment defined as:
Creatinine: ≤ 2.0 mg/dL
Hepatic: SGOT and SGPT < 5 x upper limit of institutional normal (ULN)
Women of child bearing potential agree to use effective contraception during therapy and for 4 months after completion of therapy
Voluntary written consent
Exclusion Criteria:
Known pregnancy - Pregnancy Category C: there are no adequate and well-controlled studies of romiplostim in pregnancy
Recurrence of AML or myelodysplastic syndrome on bone marrow evaluation done within 21 days of enrollment
Presence of clinically significant bone marrow fibrosis on the bone marrow examination immediately prior to UCBT
Patients requiring more than one platelet transfusion per day
History of an allergy to romiplostim
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There is 1 Location for this study
Minneapolis Minnesota, 55455, United States
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